Swine Flu, to vaccine or not to vaccine

Sep 3, 2009

Dear Dr. Bob,
There's talk that a swine flu vaccine will be rolled out in Australia (where I live) in the near future. However, I've also read that the proposed multi-dose procedure is not safe from a cross-infection perspective. Have a look at this which appears to be from a fairly authoritative source:

http://www.abc.net.au/news/stories/2009/08/20/2662321.htm

The question is then, if they do go ahead with this archaic method, is there a danger of cross infection ?

Thank you

Response from Dr. Frascino

Hello,

There is no risk to the public if the vaccines from multi-dose vials are appropriately administered. I have not heard similar concerns from other professional medical or public health organizations around the world. Certainly single-dose vials would be preferable; however, if that delays the vaccination program the consequences could be catastrophic. All things considered, I believe the decision to use the multi-dose vials is completely justified. Statements that "the epidemic has now subsided" are misleading. This pandemic remains dynamic and volatile. I, for one, will be rolling up my sleeve to get vaccinated.

I'll reprint below the latest information and recommendations concerning H1N1 in the United States from the Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC).

Dr. Bob

Interim GuidanceHIV-Infected Adults and Adolescents: Considerations for Clinicians Regarding Novel Influenza A (H1N1) Virus
June 5, 2009 2:00 PM ET
Background
Human infections with a novel influenza A (H1N1) virus that is transmissible among humans were first identified in April 2009 with cases in the United States and Mexico. The epidemiology and clinical presentations of these infections are currently under investigation. There are insufficient data available at this point to determine who is at higher risk for complications of novel influenza A (H1N1) virus infection. However, adults and adolescents with HIV infection, especially persons with low CD4 cell counts, are known to be at higher risk for viral and bacterial lower respiratory tract infections and for recurrent pneumonias.
Evidence that influenza can be more severe for HIV-infected adults and adolescents comes from studies among HIV-infected persons who had seasonal influenza; these data are limited. However, several studies have reported higher hospitalization rates, prolonged illness and increased mortality, especially among persons with AIDS. Thus, immune compromised persons, including HIV-infected adults and adolescents and especially persons with low CD4 cell counts or AIDS can experience more severe complications of seasonal influenza and it is possible that HIV-infected adults and adolescents are also at higher risk for novel influenza A (H1N1) virus infection complications.
Clinical Presentation
HIV-infected adults and adolescents with novel influenza A (H1N1) virus infection would be expected to present with typical acute respiratory illness (e.g., cough, sore throat, rhinorrhea) and fever or feverishness, headache, and muscle aches. For some HIV-infected persons, especially persons with low CD4 cell counts, illness might progress rapidly, and might be complicated by secondary bacterial infections including pneumonia. HIV-infected persons who have suspected novel influenza A (H1N1) virus infection should be tested (see Guidance on Specimen Collection), and specimens from HIV-infected persons who have unsubtypeable influenza A virus infections should be sent to the state public health laboratory for additional testing to identify novel influenza A (H1N1).
Persons with HIV infection should remain vigilant for the signs and symptoms of influenza, as outlined above. Persons with HIV infection who are concerned that they might be experiencing signs or symptoms of influenza infection, or who are concerned they might have been exposed to a confirmed, probable or suspected case of influenza infection, either seasonal influenza or novel influenza A (H1N1), should consult their healthcare provider to assess the need for evaluation and for possible anti-influenza treatment or prophylaxis.
Treatment and chemoprophylaxis
The currently circulating novel influenza A (H1N1) virus is sensitive to the neuraminidase inhibitor antiviral medications zanamivir and oseltamivir, but is resistant to the adamantane antiviral medications, amantadine and rimantadine. HIV-infected adults and adolescents who meet current case-definitions for confirmed, probable or suspected novel influenza A (H1N1) virus infection (see Guidance on Case Definitions) should receive empiric antiviral treatment. HIV-infected adults and adolescents who are close contacts of persons with probable or confirmed cases of novel influenza A (H1N1) virus infection should receive antiviral chemoprophylaxis. Antiviral chemoprophylaxis with either oseltamivir or zanamivir can be considered for HIV-infected persons who are household close contacts of a suspected case.
These recommendations for treatment and chemoprophylaxis are the same ones used for others who are at higher risk of complications from influenza. As is recommended for other persons who are treated, antiviral treatment with zanamivir or oseltamivir should be initiated as soon as possible after the onset of influenza symptoms, with benefits expected to be greatest if started within 48 hours of onset based on data from studies of seasonal influenza. However, some data from studies on seasonal influenza indicate benefit for hospitalized patients even if treatment is started more than 48 hours after onset. Recommended duration of treatment is five days. Recommended duration of prophylaxis is 10 days after last exposure. Oseltamivir and zanamivir treatment and chemoprophylaxis regimens recommended for HIV-infected persons are the same as those recommended for adults who have seasonal influenza. Clinicians should monitor treated patients closely and consider the need to extend therapy based on the course of illness. Recommendations for use of influenza antivirals for HIV-infected adults and adolescents might change as additional data on the benefits and risks of antiviral therapy in such persons become available.
No adverse effects have been reported among HIV-infected adults and adolescents who received oseltamivir or zanamivir. There are no known absolute contraindications for co-administration of oseltamivir or zanamivir with currently available antiretroviral medications.
Other ways to reduce risk for HIV-infected adults and adolescents
There is no vaccine available yet to prevent novel influenza A (H1N1) virus infection.
The risk for novel influenza A (H1N1) virus infection might be reduced by taking steps to limit possible exposures to persons with respiratory infections. These actions include frequent handwashing, covering coughs, and having ill persons stay home, except to seek medical care and for other necessities, and minimize contact with others in the household who may be ill with novel influenza A (H1N1) virus infection . Additional measures that can limit transmission of a new influenza strain include reduction of unnecessary social contacts, and avoidance whenever possible of crowded settings in communities where novel influenza A (H1N1) is circulating. If used correctly, facemasks and respirators may help reduce the risk of getting influenza, but they should be used along with other preventive measures, such as avoiding close contact with ill persons and maintaining good hand hygiene. Interim guidance regarding recommendations for facemask and respirator use as a means to decrease the risk of getting novel influenza A (H1N1) virus infection is available. This guidance will be updated as more information becomes available, including information on the risk of novel influenza A (H1N1) virus-related complications among HIV-infected adults and adolescents.
Patients should be reminded of the importance of maintaining their health as a means of reducing their risk of infection with influenza and improving their immune system's ability to fight an infection should it occur. In particular, patients who are currently taking antiretrovirals or antimicrobial prophylaxis against opportunistic infections should be reminded of the importance of adhering to their prescribed treatment.
H1N1 (Swine Flu) Immunization Campaign
Are you planning a novel H1N1 flu vaccination program here in the U.S.?
Yes, we are preparing for an H1N1 vaccination campaign. Working with Congress, governors, mayors, state and local health departments, the medical community and our private sector partners, the administration has been actively preparing for a range of H1N1 virus outbreak scenarios that may develop over the next few months and will prepare action plans based on the best scientific information available to help our nation respond aggressively to H1N1.
As we prepare for the fall flu season, we will be working closely with our partners in the medical community to develop, test, purchase and distribute vaccines as well as medicines to treat those who may contract the H1N1 virus.
We are making every effort to have a safe and effective H1N1 vaccine available for distribution as soon as mid-October, but it is possible, even probable, that epidemics may begin in different parts of the country before then. This makes prevention even more critical.
Over the course of the next few months, with the assistance of our partners in the private and public sector and at every level of government, we will move aggressively to prepare the nation for the possibility of a more severe outbreak of the H1N1 virus. We will do all we can to plan for different scenarios. We ask the American people to become actively engaged with their own preparation and prevention. It's a responsibility we all share.
Who will be recommended as priority groups to receive the novel H1N1 vaccine?
On July 29, 2009, the Advisory Committee on Immunization Practices (ACIP)an advisory committee to CDCrecommended that novel H1N1 flu vaccine be made available first to the following five groups:
Pregnant women
Health care workers and emergency medical responders
People caring for infants under 6 months of age Children and young adults from 6 months to 24 years
People aged 25 to 64 years with underlying medical conditions (e.g. asthma, diabetes)
Combined, these groups would equal approximately 159 million individuals.
Why are these priority groups different than those listed in your previous pandemic plans?
Our pandemic plans developed over the past several years were just thatplans. Our previous planning guidance was intended to provide strong advice to support planning an effective and consistent pandemic response by States and communities. Nevertheless, it is important that plans are flexible as the guidance may need to be modified based on the status of vaccine technology, the characteristics of pandemic illness, and risk groups for severe disease factors that will remain unknown until a pandemic actually occurs.
It is recognized that the supply of the novel H1N1 vaccine will not be available all at once, but rather, be produced at a rate that depends on both efficiency of production and manufacturing capacity. Given that the novel H1N1 influenza vaccine supply will continue to be available over time, allocation decisions needed to be made.
The priority groups identified during that planning process were based on what we projected might occur with a hypothetical virus in a future influenza pandemic. Now that an actual flu pandemic has arrived, we must be flexible and adjust our response based on the nature of the actual virus that has emerged, is circulating and causing disease around the world. Based on what we know now about the novel H1N1 virus and the most vulnerable groups that are being affected most by this virus and those most likely to encounter it younger people, pregnant women, healthcare personnel, and people who have underlying health conditionsit is necessary to revise and refine our vaccine prioritization guidance based on real world events
Where will the vaccine be available?
Every state is developing a vaccine delivery plan. Vaccine will be available in a combination of settings such as vaccination clinics organized by local health departments, healthcare provider offices, schools, and other private settings, such as pharmacies and workplaces.
How are you going to vaccinate everyone in this country and how are we going to pay for it?
The President and the Congress are committed to doing everything we can to keep the American people safe and have allocated funding that can be used to produce vaccine components necessary to protect Americans. To date, HHS has have already invested more than $1 billion to produce a bulk supply of vaccine and to prepare pilot lots of potential vaccine for use in clinical studies.
In addition Congress passed and President Obama recently signed a supplemental appropriation for $7.5 billion to cover the costs of preparing for H1N1 including a vaccination campaign.
As we prepare for the fall flu season, we will be working closely with our partners in the medical community to develop, test, distribute and produce flu vaccines for prevention and anti-virals administer an H1N1 flu vaccine and to distribute and dispense antiviral medications for those who may require treatment.
We will make every effort to have a safe and effective H1N1 vaccine available for distribution to those who are identified as target audiences as soon as possible, but our current estimate is that a vaccine for H1N1 won't be ready for distribution until mid-October. This fact makes prevention even more critical.
The process of making and testing a vaccine is already underway and decisions regarding vaccine formulation and dosing will be informed by the clinical studies that will start later this summer. Not everyone in the country may need an H1N1 vaccine. We will know more once the clinical trials are complete.
Will HHS be providing liability protection for vaccine manufacturers? And will HHS compensate eligible individuals who might be injured by a vaccine?
On June 15, 2009, HHS Secretary Sebelius signed a declaration under the Public Readiness and Emergency Preparedness (PREP) Act to extend liability immunity against tort claims (except for willful misconduct) to individuals and entities involved in all stages of 2009 H1N1 influenza vaccine development, testing, manufacture, distribution, prescribing, administration, and use. Liability immunity means that there is no legal tort claim that can be pursued in state or federal court. Individuals and entities that receive liability immunity under the declaration include manufacturers, distributors, States, locals, Tribes, and other entities that supervise or administer a vaccination program, and healthcare professionals or others authorized under State law to prescribe, administer, and dispense vaccines, when they are carrying out activities in accordance with the conditions stated in the declaration. One condition of the declaration is that the vaccination activities must relate to a present or future federal contract, grant, cooperative agreement, interagency agreement, or memorandum of understanding. Vaccines procured by the federal government for distribution are included. PREP Act declarations are intended to encourage manufactures to produce vaccine, and other entities to participate in distribution, dispensing, administration, and use of the vaccine.
The PREP Act also authorizes the Department to establish a compensation program when a declaration is issued under the Act. Funds for a compensation program were provided under the June 24 Supplemental Appropriations Act. The Department is currently working on developing a compensation program for eligible individuals who sustain covered injuries following vaccination.

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